# DEN220052: BrachyGel Vaginal Hydrogel Packing System

- Pathway: De Novo (Direct)
- Applicant: Brachyfoam, Inc. D/B/A Advaray
- Decided: Aug 22, 2023 after 362 days
- Product code: QXR (Vaginal Hydrogel Packing System)
- Device class: 2
- Regulation: 21 CFR 892.5735
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The BrachyGel Vaginal Hydrogel Packing System is a single-use, non-sterile, disposable, non-powered positioning device that delivers self-expanding hydrogel that forms and expands within the vaginal cavity. The purpose of this device is to displace the vaginal wall and adjacent pelvic tissues during radiation therapy planning and delivery, to reduce dose to adjacent tissues by attenuation of radiation dose, and to stabilize radiation treatment equipment during radiation therapy planning and delivery. The placement of the hydrogel device requires a physician or physician directed healthcare professional, and is performed as a separate procedure outside of brachytherapy applicator insertion, computed tomography and/or magnetic resonance imaging exam, radiation treatment planning and radiation treatment delivery. This device is not intended to be inserted into the uterine cavity or rectum. This device is intended to be in place temporarily and removed after less than 24 hours.

Source page: https://510kreport.com/device/DEN220052
Methodology: https://510kreport.com/methodology